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4A.01

This section relates to exceptions to patentability and novelty. It is so framed to have, as nearly as practicable, the same effect in the UK as the corresponding provisions of the EPC, PCT and CPC, ie Articles 53(c), 54(4) and 54(5) of the EPC.

The Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Intellectual Property Office provide further details on practice in this field.

s.130(7) is also relevant

4A.02

The term therapy includes the prevention as well as the treatment or cure of disease, as held by the Patents Court in Unilever Limited (Davis) Application, [1983] RPC 219. Although some medical dictionaries cited pointed towards a narrow interpretation of the term, other works of reference, including non-specialist dictionaries, indicated a more general meaning; this was preferred in this case, following the principle that words in statutes dealing with matters relating to the general public are presumed to be used in their popular, rather than their narrowly legal or technical, sense. However, for a treatment to constitute therapy there must be a direct link between the treatment and disease state being cured, prevented or alleviated, as held by the hearing officer in Commonwealth Scientific and Industrial Research Organizations Application (BL O/248/04). A photodynamic method of controlling wool growth to reduce the incidence of blowfly strike and balanitis in sheep was therefore determined not to be a method of therapy. Furthermore, in Schering AGs Application [1971] RPC 337, it was held that a method of chemical contraception was not considered to be therapeutic. The prohibition does apply if a method of chemical contraception is associated with a therapeutic method by means of combined delivery system. This was decided by the EPO Technical Board of Appeal in The General Hospital Corporations Application T820/92 (OJEPO 3/95) in which certain steroids were used in conjunction with a main contraceptive ingredient to alleviate health problems caused by that ingredient. The EPO Board of Appeal in another case, T74/93 (OJEPO headnote 4/95), confirmed that methods of contraception in general are not considered to be therapeutic, as pregnancy is not a disease. The Board held that the claimed method in this case lacked industrial applicability as it was a purely personal method carried out in private. In the UK methods of contraception are not considered to lack industrial application merely because they are for private and personal use. Under 60(5)(a) of the Patents Act 1977 the private use of such a method would not constitute an infringing act, and so a patent to such a method is allowable.

4A.03

It appears that any medical treatment of a disease, ailment, injury or disability, ie anything that is wrong with a patient and for which they would consult a doctor, as well as prophylactic treatments such as vaccination and inoculation, is to be regarded as therapy. The same considerations apply for animals as for human patients, so that for example prophylaxis and immunotherapy in animals are regarded as therapy.

4A.03.1

In Bristol-Myers Squibb v Baker Norton Pharmaceuticals Inc [1999] RPC 253, Jacob J held that the exception should be construed narrowly. Its purpose is merely to keep patent law from interfering directly with what a doctor actually does to a patient, not to stop patent monopolies from controlling what the doctor administers to the patient or the implements that they use on the patient. However methods of therapy carried out on materials temporarily removed from the body, for example when blood is circulated through an apparatus while remaining in living communication with the body, are not patentable (cf Calmic Engineering Co Ltds Application, [1973] RPC 684).

4A.03.2

In Ciba-Geigy AGs Application (BL O/30/85), objection was raised under now repealed section 4(2) (equivalent to s.4A(1)) to certain claims for a method of controlling parasitic helminths (worms which may develop in the animal body, for example, in the intestinal tract of animals such as sheep) by the use of a particular (novel and inventive) anthelmintic composition. The hearing officer considered that such an infestation was a disease requiring medical treatment of the animal and that such treatment, whether curative or preventative, constituted therapy practised on the animal body and consequently held that the claims in question were not allowable.

4A.03.3

Section 4A(1) excludes only treatment by surgery or therapy, and it follows that other methods of treatment of live human beings or animals, eg treatment of a sheep in order to promote growth, to improve the quality of mutton or to increase the yield of wool, are patentable provided that (as would probably be the case) such methods are of a technical, and not essentially biological, character. However, where an increase in meat yield or other industrial benefit is merely an inevitable consequence of improved health through therapeutic treatment, then such a method is unpatentable. On the other hand, a claim to the non-therapeutic use of antibiotics or other drugs may be acceptable if the claimed effect is not a mere consequence of improved health. Where the method set out in the claim may be patentable but could also cover non-patentable embodiments, a claim must be clearly limited (e.g. by a disclaimer) to methods which are patentable, and there must be support in the description for a non-therapeutic method. If necessary, the description should be amended to clarify that therapeutic methods do not form the invention.

4A.04

Application of substances to the body for purely cosmetic purposes is not therapy. In allowing claims to a process for improving the strength and elasticity of human hair and finger nails, the High Court of Australia observed that, while a process for the treatment of the human body as a means of curing or preventing a disease or other disorder was not patentable,

Those who apply chemical preparations to the skin to prevent sunburn in climates which enjoy sunshine and moderate air temperatures can scarcely be regarded either as, in a relevant sense, treating their bodies or as undergoing treatment. On the other hand, the application to the skin of an ointment designed and effective to remove keratoges from the skin would be an instance of medical treatment. To be treatment in the relevant sense, it seems to me that the purpose of the application to the body whether of a substance or a process must be the arrest or cure of a disease or diseased condition or the correction of some malfunction or the amelioration of some incapacity or disability.(Joos v Commisioner of Patents, [1973] RPC 59).

4A.05

In Oral Health Products Inc (Halsteads) Application, [1977] RPC 612, claims to a method of removing dental plaque and/or caries were refused, as was a claim to a method of cleaning teeth which embraced both curative and cosmetic effects. This decision has been followed under the 1977 Act in ICI Ltds Application No 7827383 (BL O/73/82), where a claim was refused to a method of cleaning teeth which removed both plaque and stains; it was argued that when applied to perfectly healthy teeth the method was purely cosmetic, but the hearing officer observed that practically all medical treatments which are preventative in nature (such as vaccination) must at times be applied to people who would have remained healthy anyway, but they remained medical treatments. It was held in Lee Pharmaceuticals Applications, [1978] RPC 51, that since one of the results of sealing pits and fissures in teeth was to prevent the onset of dental decay, the purpose of the treatment was therapeutic rather than cosmetic.

4A.06

Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Determination of the general physical state of an individual (e.g. a fitness test) is not considered to be diagnostic if it is not intended to identify or uncover a pathology. Section 4A(1) relates to methods of diagnosis practised on the human or animal body; diagnosis in itself is a method of performing a mental act and is

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